NCT Number: NCT00025077
Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may shrink the tumor so that it can be removed during surgery or radiation therapy. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy and allow doctors to give higher doses of chemotherapy.
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.
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Notify MeKey information
Conditions
Age range
Up to 20 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Our Lady's Hospital for Sick Children Crumlin, Dublin, Ireland
About this study
OBJECTIVES:
- Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa, carboplatin, and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors.
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Cytoreductive Phase: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 7 and continuing until blood counts recover. Treatment repeats after discontinuation of G-CSF for 2-4 courses. Peripheral blood stem cells (PBSC) are harvested after each course of cyclophosphamide. Patients undergo surgical resection or radiotherapy after the completion of chemotherapy. Patients achieving complete response proceed to myeloablative therapy.
- Myeloablative Phase: Patients receive thiotepa IV over 3 hours on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Beginning 2 days after the completion of G-CSF, patients receive carboplatin IV over 1 hour on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover.
Patients are followed at 1, 3, 6, and 12 months.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent medulloblastoma or supratentorial primitive neuroectodermal and pineal tumor
- Nodular/desmoplastic medulloblastoma
- Medullomyoblastoma
- Melanotic medulloblastoma
- Ependymoblastoma
- Pinealoblastoma
- Received prior craniospinal radiotherapy OR
- Relapse in site of prior localized radiotherapy (e.g., relapse after "baby brain" protocol)
PATIENT CHARACTERISTICS:
Age:
- Under 21
Performance status:
- Lansky 40-100% for ages 1-16 years
- Karnofsky 40-100% for ages over 16 years
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than upper limit of normal (ULN)
- AST less than 2 times ULN
Renal:
- Glomerular filtration rate at least 60 mL/min
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Treatment and study plan
carboplatin
DrugCyclophosphamide
DrugThiotepa
Drugconventional surgery
Procedureperipheral blood stem cell transplantation
Procedureradiation therapy
RadiationPrimary outcomes
-
Event-free survival
Secondary outcomes
-
Toxic death rate
Sponsors and collaborators
Lead sponsor
Children's Cancer and Leukaemia Group
Other
Registry information
Official study title
Treatment Of Recurrent Central Nervous System Primitive Neuroectodermal Tumors (PNETs) In Children And Adolescents A Strategy Including The Use Of High Dose Thiotepa And High Dose Carboplatin
Important dates
- Study start
- 2000
- Study completion
- 2011
- First posted
- Jan 27, 2003
- Registry last updated
- Aug 2, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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